A study to assess the effect of Aleglitazar on responsiveness (sensitivity) to insulin in patients with type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Adult patients with type 2 diabetes, 30-70 years of age, treated with stable metformin therapy for at least 12 weeks
•HbA1c = 6.5% and = 9% and fasting plasma glucose = 13.3 mmol/L (= 240 mg/dL)
•Overweight (BMI = 25)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Type 1 diabetes
•Previous treatment with a thiazolidinedione or dual PPAR agonist; prior intolerance to fibrate
•Treatment with any anti-diabetes medication other than stable dose metformin within the last 12 week
•Treatment any body weight lowering or lipoprotein-modifying therapy (eg, fibrates) within 12 weeks with the exception of statin therapy
•History of bariatric surgery
•Anaemia
•Estimated glomerular filtration rate <60mL/min/1.73m2
•Symptomatic congestive heart failure classified as NYHA class II-IV

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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A study to assess the effect of Aleglitazar on responsiveness (sensitivity) to insulin in patients with type 2 diabetes

Recruitment & Eligibility

Study & Design

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